DRKS00003149招募中2 期
COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide in Heart Failure: a Phase II, Multicentre, Randomised, Double-blind and Placebo-controlled Study With Parallel Groups - COR-1/02
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Signed written informed consent
- •Heart failure due to dilated cardiomyopathy and detection of anti-ß1-AR autoantibodies
- •LVEF less than or equal to 45% as determined by biplane echocardiography
- •NYHA class II - III
- •symptomatic heart failure >1 year and <8 years prior to screening date
- •Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers and aldosterone antagonists (the latter at the discretion of the attending physician) for at least 6 months (with the exception of lack of tolerability of any of these drugs) and at stable doses for at least 2 months prior to screening
排除标准
- •1) Sex and reproductive Status:
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product.
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test on enrolment or prior to investigational product administration.
- •2) Target disease exceptions
- •ischemic heart disease characterised by = 50% coronary artery stenosis as determined by coronary angiography
- •history of myocardial infarction
- •third or higher degree valvular defect
- •3) Medical History and concurrent disease
- •Clinically relevant disorder of the immune system (as determined by anamnesis)
- •History of severe allergies, increased risk for anaphylactic shock (as determined by anamnesis e.g. bronchial asthma)
- •Clinically relevant endocrine disorder (patients with insulin-dependent diabetes mellitus may be included if HbA1c is < 8.5 % and no severe nerve damage or ulceration of lower extremities are observed upon physical examination)
- •Thyroid disorder with abnormal T3/T4 values, TSH values may deviate (patients may be rescreened if T3/T4 values have normalised 2 months after initial screening)
- •Implanted cardiac defibrillator (ICD) <1 month before screening
- •Cardiac resynchronisation therapy (CRT) <6 months before screening
- •Active infectious disease, or signs of ongoing infection with a serum level of C-reactive protein (CRP) >100 mg/dl
- •Impaired renal function (glomerular filtration rate (GFR) <30 ml/min/1.73m² according to Modification of Diet in Renal Disease (MDRD) formula)
- •Anaemia (haemoglobin below 90 g/L)
- •Presence of a malignant tumour, or remission of malignancy < 5 years if life expectancy is less than 2 years
- •A second life-threatening disease with poor prognosis (survival less than 2 years)
- •Any severe liver dysfunction (transaminase levels increased to more than 5-fold of upper normal range limit or cholinesterase levels decreased to less than one third of normal range limit)
- •Congenital neuromuscular disorder or myasthenia gravis (as determined by anamnesis)
- •4) Prohibited Treatments and/or therapies
- •I.v. medication with inotropic drugs, vasodilators or repeated i.v. administration of diuretics (>1/day).
- •Any disease requiring immunosuppressive drugs, except = 5 mg/day prednisone-equivalent dose
- •Participation in any other interventional study within less than 30 days prior to screening date
- •5) Other Exclusion criteria
- •Inability to provide informed consent
- •Suspected poor capability to follow instructions and cooperate
- •Prisoners or subjects who are involuntarily incarcerated
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
- •Ongoing drug or alcohol abuse
研究者
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